Drug Information Center College of Pharmacy Highlights of FDA Activities – 5/1/17 – 5/31/17 FDA Drug Safety Communications & Drug Information Updates: Fluoroquinolone Antibiotics: Drug Safety Communication – Disabling Side Effects 5/10/17 The FDA informed consumers and prescribers that current clinical studies do not support earlier reports that fluoroquinolone antibiotics are associated with retinal detachment, or with aortic aneurysms or aortic dissections. Canagliflozin : Drug Safety Communication ‐ Increased Risk of Leg and Foot Amputations 5/16/17 The FDA is requiring a new Boxed Warning for canagliflozin (Invokana, Invokamet, Invokamet XR) to describe an increased risk of leg and foot amputations associated with canagliflozin. According to the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS‐R clinical trials (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) patients treated with canagliflozin were twice as likely to have leg and foot amputations compared to patients treated with an inactive placebo. Magellan Diagnostics LeadCare Testing Systems: Drug Safety Communication – Inaccurate Results 5/17/17 The FDA is warning consumers that certain lead tests manufactured by Magellan Diagnostics (LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra) may provide inaccurate results; see recall information below. Gadolinium‐based Contrast Agents: Drug Safety Communication – No Harmful Effects from Retention 5/22/17 The FDA provided an update on ongoing monitoring of the safety of gadolinium‐based contrast agents retained in the brain following use for Magnetic Resonance Imaging. Although gadolinium is retained in the brain, the FDA found no evidence that retention is harmful. They will continue to monitor and advise health care professionals to limit use of these agents to circumstances in which they are necessary, but are not placing restrictions on their use at this time. Major Product Recalls Announced Through MedWatch: ReFlow Medical Wingman35 Crossing Catheters: Recall – Tip Splitting or Separation 5/3/17, 5/17/17 ReFlow Medical recalled the Wingman35 Crossing Catheters due to the possibility of tip splitting or separation. Amitriptyline Tablets & Phenobarbital Tablets from C. O. Truxton, Inc.: Recall – Label Mix‐up 5/8/17 C. O. Truxton, Inc. is expanding their recall (4/21/17) to include specific lots of amitriptyline 50 mg tablets (NDC 0463‐6352‐10), and phenobarbital 15 mg (NDC 0463‐6161‐10), 30 mg (NDC 0463‐6145‐10), 60 mg (NDC 0463‐6151‐ 10), and 100 mg (NDC 0463‐6152‐01; 0163‐6152‐10; 0463‐6152‐01) tablets. Refer to the following link for specific lot numbers and expiration dates: https://www.fda.gov/Safety/Recalls/ucm557260.htm Abbott Coronary Catheters: Recall – Difficulty in Removing Balloon Sheath 5/16/17 Abbott recalled the NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter due to difficulty in removing the protective balloon sheath. The lots affected were manufactured from 1/1/15 to 1/2/17, and were distributed from 1/13/15 to 3/14/17. Respironics V60 Non‐invasive Ventilator: Class I Recall 5/22/17 Respironics V60 Non‐invasive Ventilator which provides continuous or intermittent breathing support to pediatric and adult patients, was recalled due to potential for pins within the internal cable that connects the ventilator’s motor to the control board to become loose over time due to low frequency vibration resulting in unexpected ventilator shut down. The recalled products were manufactured from 4/2/09 to 9/15/15 and distributed from 4/4/09 to 9/14/15. Refer to the following link for the affected serial numbers: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154944 FDA Activity Newsletter WSU Drug Information Center May 2017 Page | 2 Abbott‐Thoratec HeartMate II LVAS Pocket System Controller: Class I Recall ‐ Risk of Patient Injury 5/23/17 and/or Death During Backup Controller Exchange Abbott‐Thoratec has received reports of 19 injuries and 26 deaths due to incidents when a patient attempted to exchange controllers for their ventricular assist device outside a hospital setting, including with The Pocket System Controller which is a power supply that connects to the implanted HeartMate II LVAS pump through a lead under the skin. Model/Item Numbers recalled are: 105109, 106015, 106762, 107801 and Manufactured July 2012 to December 2016. Magellan Diagnostic LeadCare Testing Systems: Recall ‐ Inaccurate Test Results 5/25/17 Magellan Diagnostic recalled all serial numbers and lots of their LeadCare Plus and LeadCare Ultra testing systems due to underestimated blood lead levels and inaccurate results from venous samples. AstraZeneca Brilinta (ticagrelor) 90 mg: Recall ‐ Another Medicine Found in 1 Bottle 5/26/17 AstraZeneca recalled lot # JB5047 sample bottles containing eight tablets of Brilinta (ticagrelor) 90mg distributed to physicians in the US between March and April of 2017, after one was found to also contain Zurampic (lesinurad) 200 mg tablets. Lupin Pharmaceuticals Inc. Mibela 24 Fe Chewable Tablets: Recall ‐ Out of Sequence Tablets and 5/30/17 Missing Expiry/Lot Information Lupin Pharmaceuticals Inc. recalled lot L600518, Exp 05/18 of Mibela 24 Fe (norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg). As a result of a packaging error, the first four days of therapy have four non‐hormonal placebo tablets as opposed to the active tablets, and the lot number and expiration date are not visible. Zimmer Biomet SpF PLUS‐Mini and SpF XL IIb Implantable Spinal Fusion Stimulators: Recall ‐ 5/30/17 Harmful Cytotoxic Chemicals Zimmer Biomet recalled the SpF PLUS‐Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs, which were found during the company's routine monitoring procedure. The use of affected product may cause serious adverse health consequences, including but not limited to chronic infections, long‐term hospitalization due to additional surgical procedures, paralysis, and death. Dietary Supplement Recalls & Public Notifications In May, the FDA issued notifications to the public regarding undeclared active ingredients in the following products. Patients are advised not to purchase or use these products. Product Promoted Use Hidden/Undeclared Drug Ingredient(s) Al‐Er‐G Capsules by MusclMasster* Weight loss Ephedra1 Big N Hard Sexual enhancement Tadalafil2 Caverflo Natural Herbal Coffee* Sexual enhancement Sildenafil, tadalafil2 Cummor Sexual enhancement N‐desmethyl tadalafil2 GEC Laxoplex Dietary Supplement* Muscle enhancement Anabolic steroids Monkey Business Sexual enhancement N‐desmethyl tadalafil2 Tornado Sexual enhancement Tadalafil2 Tri‐Ton by Dynamic Technical Formulations* Muscle enhancement Anabolic steroids (andarine and ostarine) Xrect Sexual enhancement Tadalafil, descarbonsildenafil2 Z Daily Sexual enhancement Homosildenafil2 *Recalled 1Ephedra was banned by the FDA in 2003 due to its association with serious adverse events including heart attack, stroke, and death 2Sildenafil/tadalafil/N‐desmethyl tadalafil/descarbonsildenafil/homosildenafil may interact with nitrates to lower blood pressure to dangerous levels FDA Activity Newsletter WSU Drug Information Center May 2017 Page | 3 New Product Shortages Reported by the FDA: Date Initially Posted Tolmetin Sodium Tablets (Mylan Pharmaceuticals, Inc.): 600 mg tablets (NDC 0378‐0313‐01) 5/16/17 Product Discontinuations/Withdrawals Date Posted Delavirdine Mesylate (Rescriptor) Tablets (ViiV Healthcare): 100 mg tablets, 360 count (NDC 49702‐ 5/11/17 209‐24); 200 mg tablets, 180 count (NDC 49702‐225‐17); delavirdine tablets will be discontinued between October 2018 and February 2020. No alternative source is currently available. Methylphenidate Hydrochloride Tablets (Novartis): 5 mg tablets, 100 count (NDC 0781‐8840‐01); 5/17/17 methylphenidate 5 mg tablets remain available from multiple manufacturers. Galantamine Tablets (Zydus Pharmaceuticals USA Inc.): 4 mg tablets, 60 count (NDC 68382‐177‐14), 8 5/22/17 mg tablets, 60 count (NDC 68382‐178‐14), and 12 mg tablets, 60 count (NDC 68382‐179‐14); galantamine tablets remain available from multiple manufacturers. Glyburide and Metformin Tablets (Zydus Pharmaceuticals USA Inc.): 1.25 mg/250 mg tablets, 100 5/22/17 count (NDC 68382‐653‐01), 2.5 mg/250 mg tablets, 100 count (NDC 68382‐654‐01) and 500 count (NDC 68382‐654‐05), 5 mg/500 mg tablets, 100 count (NDC 68382‐655‐01) and 500 count (NDC 68382‐655‐05); glyburide and metformin tablets remain available from multiple manufacturers. Glyburide Tablets (Zydus Pharmaceuticals USA Inc.): 1.25 mg tablets, 100 count (NDC 68382‐656‐01), 5/22/17 2.5 mg tablets, 100 count (NDC 68382‐657‐01) and 500 count (NDC 68382‐657‐05), 5 mg tablets, 100 count (NDC 68382‐658‐01) and 1000 count (NDC 68382‐658‐10); glyburide tablets remain available from multiple manufacturers. Indomethacin Capsules (Zydus Pharmaceuticals USA Inc.): 25 mg capsules, 100 count (NDC 68382‐293‐ 5/22/17 01) and 1000 count (NDC 68382‐293‐10), 50 mg capsules, 100 count (NDC 68382‐294‐01) and 500 count (NDC 68382‐294‐01); indomethacin capsules remain available from multiple manufacturers. New Drug Approvals: Description Date Approved Durvalumab / Imfinzi / AstraZeneca See attached drug summary 5/1/17 Edaravone / Radicava / MT Pharma See attached drug summary 5/5/17 America, Inc. Sarilumab